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NCT01227889 · OUTCOME

Overall Survival

A Study Comparing GSK2118436 to Dacarbazine (DTIC) in Previously Untreated Subjects With BRAF Mutation Positive Advanced (Stage III) or Metastatic (Stage IV) Melanoma · Source last updated 2017-10-04

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Months
Interval / dispersion
95% Confidence Interval
Time frame
Time interval between the date of randomization and the date of death due to any cause (up to 22.1 months)

What was measured

Overall survival is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, overall survival was censored at the date of last contact.

Analysis population: ITT Population

Groups in this outcome

GSK2118436 150 mg BID

Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.

DTIC 1000 mg/m^2 in RP

In the RP, participants received IV DTIC 1000 mg/m\^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
GSK2118436 150 mg BID187
DTIC 1000 mg/m^2 in RP63

Reported measurements

Source class 1
Values in Months · Interval/dispersion: 95% Confidence Interval
GroupValueSpreadLowerUpperComment
GSK2118436 150 mg BID20.0Not reported16.724.2Not reported
DTIC 1000 mg/m^2 in RP15.6Not reported11.921.2Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    estimate Comment
    HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
Complete source fields
analyses
  1. ci Lower Limit
    0.57
    ci Num Sides
    TWO_SIDED
    ci Pct Value
    95
    ci Upper Limit
    1.18
    estimate Comment
    HRs were estimated using a Pike estimator. HR was adjusted for disease stage at screening.
    group Ids
    1. OG000
    2. OG001
    non Inferiority Type
    OTHER
    param Type
    Hazard Ratio (HR)
    param Value
    0.82
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        lower Limit
        16.7
        upper Limit
        24.2
        value
        20.0
      2. group Id
        OG001
        lower Limit
        11.9
        upper Limit
        21.2
        value
        15.6
denoms
  1. counts
    1. group Id
      OG000
      value
      187
    2. group Id
      OG001
      value
      63
    units
    Participants
description
Overall survival is defined as the interval of time between the date of randomization and the date of death due to any cause. For participants who did not die, overall survival was censored at the date of last contact.
dispersion Type
95% Confidence Interval
groups
  1. description
    Participants were randomly assigned to receive oral GSK2118436 150 mg BID. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study. Participants who experienced investigator-reported DP but were benefitting from study treatment were permitted to continue GSK2118436 treatment upon approval of the GlaxoSmithKline Medical Monitor.
    id
    OG000
    title
    GSK2118436 150 mg BID
  2. description
    In the RP, participants received IV DTIC 1000 mg/m\^2 every 3 weeks. Dose reductions were permitted based on the severity of the hematological toxicity. Stopping recommendations for study treatment were also provided for cases of reoccurring skin toxicity, cardiovascular complication or abnormalities, and liver abnormalities. Participants. continued on treatment until DP, death, the occurrence of an unacceptable AE, or withdrawal from the study.
    id
    OG001
    title
    DTIC 1000 mg/m^2 in RP
param Type
MEDIAN
population Description
ITT Population
reporting Status
POSTED
time Frame
Time interval between the date of randomization and the date of death due to any cause (up to 22.1 months)
title
Overall Survival
type
SECONDARY
unit Of Measure
Months

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice